12.12.2023 14:22:40

Blueprint Medicines Announces European Commission Approval For AYVAKYT - Quick Facts

(RTTNews) - Blueprint Medicines Corporation?(BPMC) announced the European Commission has approved AYVAKYT for the?treatment of adult patients with indolent systemic mastocytosis with moderate to severe symptoms inadequately controlled on symptomatic treatment. The company said the approval follows the positive opinion by the Committee for Medicinal Products for Human Use. The EC decision was based on data from the double-blind, placebo-controlled PIONEER trial.

Georg Pirmin Meyer, Senior Vice President, International at Blueprint Medicines, said: "For the first time in Europe ISM patients have an approved therapy, marking a new era in the treatment of this disease. AYVAKYT is the first approved medicine for both ISM and advanced SM."

In Europe, the company plans to initiate first commercial launch in Germany, followed by additional markets.

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